MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII LONG I/M ROD 16 INCH; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported, that a genesis ii long i/m rod 16 inch was found chipped.No case reported; therefore, there was no patient involvement.

• Brand Name: GII LONG I/M ROD 16 INCH
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12494518
• Report Number: 1020279-2021-06991
• Device Sequence Number: 4986309
• Product Code: HRY
• UDI-Device Identifier: 03596010213723
• UDI-Public: 03596010213723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71440004
• Device Catalogue Number: 71440004
• Device Lot Number: 16AM05196
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1